Combination Chemotherapy Following Surgery in Treating Patients With Urinary Tract Cancer

Tulane University Health Sciences Center

Status and phase

Completed

Phase 2

Conditions

Transitional Cell Cancer of the Renal Pelvis and Ureter

Bladder Cancer

Treatments

Procedure: adjuvant therapy

Biological: filgrastim

Drug: paclitaxel

Drug: gemcitabine hydrochloride

Drug: ifosfamide

Drug: carboplatin

Study type

Interventional

Funder types

Other

Identifiers

NCT00028860

BMS-TULCC-RM-002

TULCC-RM-002

AMGEN-TULCC-RM-002

CDR0000069142 (Registry Identifier)

Details and patient eligibility

About

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy following surgery in treating patients who have urinary tract cancer.

Full description

OBJECTIVES:

Determine the time to treatment failure and disease-free survival in patients with high-risk transitional cell carcinoma of the urothelium treated with adjuvant paclitaxel, ifosfamide, carboplatin, and gemcitabine.
Determine the tolerability and feasibility of this regimen in these patients.

OUTLINE: Patients are stratified according to disease stage.

Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 1 hour on day 1, ifosfamide IV over 1 hour on days 1-3, and filgrastim (G-CSF) subcutaneously (SC) once daily beginning on day 4 and continuing until blood counts recover. Treatment repeats every 21 days for a total of 2 courses.

Beginning 3 weeks after the completion of the second course of chemotherapy, patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 1 hour on day 1. Patients also receive G-CSF SC once daily on days 2-6 and again beginning on day 9 and continuing until blood counts recover. Treatment repeats every 21 days for a total of 2 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed at 3 months, every 6 months for 2 years, and then annually for 3 years.

PROJECTED ACCRUAL: A total of 10-30 patients will be accrued for this study.

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

Diagnosis of transitional cell carcinoma of the urothelium including bladder, ureter, and renal pelvis
- T3b-4, N0, M0 OR
- Any T, N1-3, M0
Cystectomy within the past 8 weeks

PATIENT CHARACTERISTICS:

Age:

Not specified

Performance status:

ECOG 0-1

Life expectancy:

At least 12 months

Hematopoietic:

Absolute granulocyte count at least 1,500/mm^3
Platelet count at least 100,000/mm^3

Hepatic:

Bilirubin no greater than 1.5 times upper limit of normal (ULN)
AST or ALT no greater than 2.5 times ULN

Renal:

Creatinine no greater than ULN
Albumin no greater than ULN

Other:

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No other prior malignancy except curatively treated carcinoma in situ of the cervix or non-melanoma skin cancer
No active serious infection, other serious underlying medical condition, dementia, or significantly altered mental status that would preclude study participation
No known hypersensitivity to Cremophor EL
No pre-existing clinically significant grade 2 or greater neuropathy
No AIDS (HIV positivity alone allowed)
No known hypersensitivity to E. coli-derived products

PRIOR CONCURRENT THERAPY:

Biologic therapy: